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Bristol Myers' (BMY) Opdivo Meets Main Goal in Melanoma Study

·4 min read

Bristol Myers Squibb BMY announced positive results from the phase III CheckMate-76K study, currently evaluating its blockbuster immuno-oncology drug Opdivo (nivolumab) as a single agent in the adjuvant setting in patients with completely resected stage IIB/C melanoma, a form of skin cancer.  Shares were up 1.9% in response to the news.

CheckMate -76K is a randomized, double-blind study evaluating adjuvant Opdivo 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB/C melanoma.

Results showed that the study met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo at a pre-specified interim analysis.

The secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2) and safety endpoints.

The positive results from CheckMate -76K reinforce the potential benefit of Opdivo in earlier stages of melanoma.

CheckMate -76K is part of Bristol Myers’ development program evaluating Opdivo and Opdivo-based combinations in earlier stages of cancer. It currently covers seven tumor types.

Shares of Bristol Myers have gained 15.1% in the year so far against the industry’s decline of 23.1%

 

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Opdivo is one of the top revenue generators for BMY. The continued label expansion of the drug for additional indications should further boost its growth potential. Label expansion of Opdivo boosted sales, driven by higher demand across multiple indications, including the Opdivo+Yervoy-based combinations for non-small cell lung cancer (NSCLC), Opdivo+Cabometyx combination for kidney cancer and Opdivo-based therapies for various gastric and esophageal cancers.

The FDA had earlier approved a new, first-in-class, fixed-dose combination of PD-1 inhibitor Opdivo and relatlimab (novel LAG-3-blocking antibody). It is administered as a single intravenous infusion to treat adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma under the brand name Opdualag.  The initial uptake of the drug has been encouraging so far.

The approval of potential new drugs and the label expansion of existing drugs will add an incremental revenue stream to boost growth in the coming quarters. This is understandable as one of Bristol Myers’ top drugs Revlimid is now facing generic competition, which is affecting the top line and threatens to erode sales rapidly.

Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) was approved in the United States for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

However, results from the mid-stage AXIOMATIC-SSP dose-ranging study of experimental candidate milvexian, announced last month, were disappointing. The candidate is being developed to prevent new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel, following an acute ischemic stroke or transient ischemic attack.

Competition is also stiff for Opdivo from the likes of Merck’s MRK Keytruda. The drug, approved for various oncology indications, is the key driver for Merck.

Bristol Myers currently carries a Zacks Rank #3 (Hold).  Two better-ranked stocks in the sector are Bolt Pharmaceuticals BOLT and Dynavax DVAX, both presently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed on earnings in three of the trailing four quarters and missed on the same in the remaining one, the average beat being 2.39%.

Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.




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